Phase 4
Completed N=357
Primovist / Eovist in Renally Impaired Patients
Contrast Media
Source: ClinicalTrials.gov NCT00908596 ↗
Enrolled (actual)
357
Serious AEs
0.3%
Results posted
Aug 2014
Primary outcomePrimary: Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information — 0; 0; 0; 0 Participants
Summary
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.
The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist.
Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Moderate to Severe Renal Impairment, Who Develop NSF (Nephrogenic Systemic Fibrosis), Based on Diagnostically Specific Clinical and Histopathological Information |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy Was Obtained Who Develop NSF-like Symptoms Based on Diagnostically Specific Clinical Information Summarized by Clinical Score |
0; 0; 0; 0 | — |
| SECONDARY Confidence of the Investigator to Make a Diagnosis Based on the Primovist/Eovist Enhanced MRI (Magnetic Resonance Imaging) |
26; 16; 98; 33; 15; 13 | — |
| SECONDARY Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Detection |
29; 20; 99; 34; 15; 12 | — |
| SECONDARY Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Delineation |
27; 16; 94; 31; 15; 16 | — |
| SECONDARY Number of Participants With "Excellent / Good / Adequate / Insufficient" Scores for Lesion Characterization |
30; 13; 93; 33; 12; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must be scheduled for Contrast enhanced magnetic resonance imaging (CE-MRI) of the liver with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
- Patient must fulfill criteria for moderate (Estimated glomerular filtration rate [eGFR] 30 - 59 mL/min/1.73 m^2) to severe (eGFR < 30 mL/min/1.73 m^2) renal impairment.
Exclusion Criteria
- Gadolinium based contrast agent (GBCA)-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
- History of existing NSF
Data sourced from ClinicalTrials.gov (NCT00908596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.